Feasibility Study to Test Clinical Efficacy of Low Energy AC Magnetic Field to Treat Major Depression

NCT01683019 | Completed Results FDA Device

• 1 other identifier: NST#002
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 2

Brief Summary

This feasibility study investigates effects of EEG-based low frequency, low emission magnetic cortical stimulation in comparison to a sham treatment in subjects with moderate to severe depressive disorder.

Conditions

Major Depressive Disorder (MDD)

Keywords

Depression; magnetic field; alpha frequency; EEG; NeoSync EEG Synchronization Therapy

Outcome Measures

Primary Outcomes (1)

• Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.

  Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment. The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression.

  Assessed at baseline and the end of Week 4 of treatment.

Study Arms (3)

Active Fixed Alpha Frequency Magnetic Stimulation

ACTIVE COMPARATOR

Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).

Device: NeoSync EEG Synchronization Therapy

Active Random Frequency Magnetic Stimulation

ACTIVE COMPARATOR

Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.

Device: NeoSync EEG Synchronization Therapy

Inactive Sham Treatment

SHAM COMPARATOR

Generate sound similar to active treatment, except that no magnetic field is generated.

Device: Sham NeoSync EEG Synchronization Therapy

Interventions

NeoSync EEG Synchronization Therapy DEVICE

Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.

Active Fixed Alpha Frequency Magnetic Stimulation; Active Random Frequency Magnetic Stimulation

Sham NeoSync EEG Synchronization Therapy DEVICE

A device that looks and sounds similar to the active treatment, but no magnetic field is generated.

Inactive Sham Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Diagnosis of MDD with HAMD-17 greater than or equal to 17
• On a stable dose of existing medication or no medication for 1 month or longer prior to the study

You may not qualify if:

• Diagnosed with another primary Axis I illness
• Recent history of or current substance abuse
• Clinically significant medical illness, including any thyroid disorders
• Known pregnancy and/or lactation, or intent to become pregnant during the study

Sponsors & Collaborators

• Wave Neuroscience: lead

Study Sites (2)

Amen Clinic

Newport Beach, California, 92660, United States

Location

Institute of Mental Health, Peking University

Beijing, China

Location

Related Publications (1)

• Jin Y, Phillips B. A pilot study of the use of EEG-based synchronized Transcranial Magnetic Stimulation (sTMS) for treatment of Major Depression. BMC Psychiatry. 2014 Jan 18;14:13. doi: 10.1186/1471-244X-14-13.

  PMID: 24438321 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Bill Phillips
• Organization: NeoSync, Inc.

bill@neosync.com

949-333-2906

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 11, 2012
• Study Start: June 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 7, 2018
• Results First Posted: May 5, 2014

Record last verified: 2018-12

Locations

US (1); CN (1)